Embolic coil proximal connecting element and stretch resistant fiber

ABSTRACT

An embolic coil implant having a stretch resistant fiber therethrough and dual-functional engagement feature at its proximal end is provided. The stretch resistant fiber can be effective to limiting separation of windings of the embolic coil. The engagement feature can provide an attachment for securing the embolic coil to an engagement system of a delivery tube and for securing the stretch resistant fiber at the proximal end of the embolic coil.

CROSS REFERENCE TO RELATED APPLICATION

The present application is a divisional application of U.S. patentapplication Ser. No. 16/573,469 filed Sep. 17, 2019. The entire contentsof which are hereby incorporated by reference.

This application is also related to continuation in part application,U.S. patent application Ser. No. 17/375,482 filed Jul. 14, 2021.

FIELD OF INVENTION

The present invention generally relates to implantable medical devices,and more particularly, to engagement features for mechanicallyreleasably securing implantable medical devices to a delivery system.

BACKGROUND

Aneurysms can be intravascularly treated by delivering a treatmentdevice to the aneurysm to fill the sac of the aneurysm with embolicmaterial and/or block the neck of the aneurysm to inhibit blood flowinto the aneurysm. When filling the aneurysm sac, the embolic materialcan promote blood clotting to create a thrombotic mass within theaneurysm. When treating the aneurysm neck without substantially fillingthe aneurysm sac, blood flow into the neck of the aneurysm can beinhibited to induce venous stasis in the aneurysm and facilitate naturalformation of a thrombotic mass within the aneurysm.

In some current treatments, multiple embolic coils are used to eitherfill the aneurysm sac or treat the entrance of the aneurysm neck. Acommon challenge among embolic coil treatments is that implanted coilsand implanted portions of partially implanted coils can become entangledand difficult to reposition. In some instances, a physician may not beable to retract a partially implanted coil and may be forced to positionthe coil in a non-ideal location. Improperly positioning embolic coilsat the aneurysm neck can potentially have the adverse effect of impedingthe flow of blood in the adjoining blood vessel, particularly if theentrance and/or sac is overpacked. If a portion of the non-ideallyimplanted coil becomes dislodged, it can enter the neighboring bloodvessel and promote clot formation, which can ultimately lead to anobstruction that is tethered to the aneurysm and therefor extremelydifficult to treat. Conversely, if the entrance and/or sac isinsufficiently packed, blood flow can persist into the aneurysm.

In some current treatments, an embolic coil is attached to a tubulardelivery member and delivered via a delivery catheter to an aneurysm.During delivery, the embolic coil can be engaged to the deliverymember's implant engagement/deployment system (referred to hereinequivalently as an “engagement system” or “deployment system”). When theembolic coil is in position, the deployment system can release the coil,the coil can be left implanted, and the delivery member can beretracted. Some treatments utilize a mechanical engagement/deploymentsystem that can be actuated by a physician to release the implant bypulling one or more wires or other elongated members referred togenerically herein as a “pull wire”.

Some of the challenges that have been associated with delivering anddeploying embolic coils with delivery members having mechanicalengagement systems include premature release of a coil and movement ofthe delivery member due to push back from densely packed treatmentsites.

There is therefore a need for improved methods, devices, and systems tofacilitate implantation of embolic coils and other implants facingsimilar challenges.

SUMMARY

It is an object of the present invention to provide systems, devices,and methods to meet the above-stated needs. In some examples presentedherein, separation of coil windings within an embolic coil is reduced orprevented with a stretch resistant fiber that is positioned within thelumen of the coil. Reducing or preventing the separation of coilwindings can in some cases prevent an implanted portion of a partiallyimplanted coil from being tangled with implanted coils and thereby makeit possible to more easily reposition and/or extract some or all of thecoil. In some examples presented herein, during delivery of the emboliccoil the distal end of the pull wire is supported by anengagement/detachment feature (referred to herein equivalently as“engagement feature”, “detachment feature”, or “key”) affixed to theproximal end of the embolic coil. The support provided by the key can insome cases reduce the likelihood that the embolic coil is prematurelyreleased. In some examples presented herein, the embolic implant canhave a highly flexible proximal portion. The flexibility of the embolicimplant can in some cases reduce the force on the delivery member due topush back from densely packed treatment sites and thereby reducemovement of the delivery member due to the push back.

To meet some or all of the needs, an implant having an embolic coil, astretch resistant fiber extended through the coil, and a detachmentfeature/key at the coil's proximal end is provided. The stretchresistant fiber can be effective to limit separation of windings of theembolic coil. The key can provide an attachment for securing the emboliccoil to an engagement system of a delivery tube and for securing thestretch resistant fiber at the proximal end of the embolic coil.

An example method for treating an aneurysm can include one or more ofthe following steps presented in no particular order, and the method caninclude additional steps not included here. Some or all of an implanthaving an embolic coil and a stretch resistant fiber can be positionedwithin the aneurysm. A portion of the embolic coil can be retracted fromthe aneurysm. The portion can be inhibited from lengthening by thestretch resistant fiber when the portion is retraced from the aneurysm.The embolic coil can be bent, and the stretch resistant fiber can limitseparation of the windings of the embolic coil at the bend.

The stretch resistant fiber can be positioned to extend within a lumenof the embolic coil. The stretch resistant fiber can under tension alonga majority of the length of the stretch resistant fiber.

The implant can be secured to a delivery system with a key engaged tothe stretch resistant fiber. To secure the implant to the deliverysystem, a loop wire of the delivery system can be positioned through thekey, and a pull wire can be positioned through an opening in the loopwire. When the implant is secured to the delivery system, the pull wirecan be supported by the key both in the proximal direction from the loopwire and the distal direction from the loop wire.

During delivery and/or positioning of the implant, the key can bevisualized radiographically.

The key can be released from the delivery system, thereby releasing theimplant from the delivery system. When the implant is released, the keycan remain attached to the implant.

An example embolic implant can include an embolic coil, a detachmentfeature, and a stretch resistant fiber. The detachment feature can beaffixed to the embolic coil at the proximal end of the embolic coil. Thestretch resistant fiber can be engaged to the detachment feature, extendthrough the lumen of the embolic coil, and can be affixed to the emboliccoil at the distal end of the embolic coil. Configured thusly, thestretch resistant fiber can be effective to limit separation of windingsof the embolic coil as the embolic coil is reshaped.

The stretch resistant fiber can be a suture. The stretch resistant fibercan be inelastic.

The detachment feature can be radiopaque.

The detachment feature can have an opening through which the stretchresistant fiber passes. The opening can extend proximally from aproximal end of the embolic coil.

The detachment feature can have a singular opening that is sized toreceive a loop wire of a mechanical delivery system and through whichthe stretch resistant fiber passes.

Alternatively, the detachment feature can have two separate openings: afirst opening through which the stretch resistant fiber passes and asecond opening sized to receive a loop wire of a mechanical deliverysystem. The first opening can be at least partially positioned withinthe lumen of the embolic coil. The second opening can be at leastpartially positioned in the proximal direction from the proximal end ofthe embolic coil.

An example system can include the example embolic implant having thedetachment feature with two separate openings and a mechanical deliverysystem including a loop wire and a pull wire. The stretch resistantfiber can pass through one of the two openings, and the loop wire canpass through the other of the two openings. The pull wire can bepositioned through an opening in the loop wire, thereby securing theimplant to the mechanical delivery system with the loop wire. Thedetachment feature can further include a bridge positioned between thetwo openings of the detachment feature, and the bridge can support aportion of the pull wire that is in the distal direction from the loopopening in the loop wire.

The detachment feature can have a proximal portion disposed proximallyfrom the lumen of the embolic coil and a distal portion disposed withinthe lumen. The proximal portion can have a width that measures greaterthan the inner diameter of the embolic coil lumen, and the distalportion can have a width that measures about equal to the inner diameterof the embolic coil lumen.

An example method for constructing or designing an embolic implant suchas an example implant as described herein can include one or more of thefollowing steps presented in no particular order, and the method caninclude additional steps not included here. A detachment feature can becut from a flat sheet material. One or more openings can be cut from thedetachment feature. A stretch resistant fiber can be threaded through anopening in the detachment feature. The stretch resistant fiber can beextended through a lumen of an embolic coil. The detachment feature canbe affixed at one end of the embolic coil. The stretch resistant fibercan be affixed at the other end of the embolic coil. Tension can beprovided along the stretch resistant fiber between the detachmentfeature and the second end of the embolic coil.

A portion of a mechanical deployment system can be extended through anopening in the detachment feature to engage the detachment feature to adelivery tube. The mechanical deployment system can be extended throughthe same opening through which the stretch resistant fiber is threadedor an opening in the detachment feature that is separate from theopening through which the stretch resistant fiber is threaded.

The detachment feature can be cut from a radiopaque flat sheet material.

A distal portion of the detachment feature can be inserted within thelumen of the embolic coil and a proximal portion of the detachmentfeature can be extended proximally from the proximal end of the emboliccoil. The embolic coil and the detachment feature can be selected suchthat the proximal portion of the detachment feature is wider than theinner diameter of the embolic coil's lumen and the distal portion of thedetachment feature is about equal to the inner diameter of the emboliccoil's lumen.

To affix the detachment feature to the embolic coil, the detachmentfeature can be welded to the embolic coil.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and further aspects of this invention are further discussedwith reference to the following description in conjunction with theaccompanying drawings, in which like numerals indicate like structuralelements and features in various figures. The drawings are notnecessarily to scale, emphasis instead being placed upon illustratingprinciples of the invention. The figures depict one or moreimplementations of the inventive devices, by way of example only, not byway of limitation.

FIGS. 1A and 1B are illustrations of embolic implants according toaspects of the present invention;

FIGS. 2A and 2B are illustrations of detachment features each having astretch resistant fiber therethrough according to aspects of the presentinvention;

FIG. 3 is an illustration of a stretch resistant fiber being insertedinto a lumen of an embolic coil according to aspects of the presentinvention;

FIG. 4 is an illustration of a stretch resistant fiber exiting a lumenof an embolic coil according to aspects of the present invention;

FIGS. 5A and 5B are illustrations of detachment features being insertedinto a lumen of an embolic coil according to aspects of the presentinvention;

FIGS. 6A and 6B are illustrations of detachment features affixed to anembolic coil according to aspects of the present invention;

FIG. 7 is an illustration of the stretch resistant fiber affixed to anend of the embolic coil according to aspects of the present invention;

FIGS. 8A through 8C illustrate a time sequence wherein an embolic coilstretches as a result of a non-optimal stretch resistant fiberplacement;

FIG. 9 is an illustration of embolic coils being positioned within ananeurysm according to aspects of the present invention;

FIG. 10A is an illustration of embolic coils becoming tangled, and

FIG. 10B is an illustration of a tangled coil becoming elongated asillustrations of a problem with the prior art;

FIG. 11 is an illustration of a stretch resistant fiber inhibitingtangling and elongating of an embolic coil according to aspects of thepresent invention;

FIG. 12 is a flow diagram outlining method steps that can be conductedas part of an aneurysm treatment according to aspects of the presentinvention;

FIG. 13 is an illustration of an embolic implant secured to a deliverytube according to aspects of the present invention;

FIGS. 14A through 14D illustrate a sequence of steps for releasing anembolic implant from a delivery tube according to aspects of the presentinvention; and

FIG. 15 is an illustration of an end of an embolic implant including adetachment feature expanding an inner diameter of an embolic coilaccording to aspects of the present invention.

DETAILED DESCRIPTION

An object of the present invention is to attain more precise andrepeatable implant detachment. More specifically, it is an object of thepresent invention to facilitate implantation of embolic coils and otherimplants facing challenges such as partially implanted implants becomingdifficult to reposition, delivery systems shifting position due to pushback during implantation, and/or implants releasing prematurely. To meetsome or all of these needs, example implants can include a stretchresistant fiber to limit stretching and other deformation of the embolicportion (e.g. embolic coil) of the implant and a detachment feature towhich the stretch resistant fiber can be secured and to which a deliverysystem can detachably attach.

To facilitate repositioning of the implant, the stretch resistant fibercan extend through the embolic coil and limit separation of windings ofthe coil when the coil is bent and pulled. By limiting the separation ofthe windings, the embolic coil is less likely to become tangled whenpartially implanted and less likely to be stretched or otherwisedeformed when retracted when partially implanted. The embolic coil canthereby be more easily repositioned. In some examples, the detachmentfeature can include two separate openings, one for securing the stretchresistant fiber, and another for being engaged to an engagement system.The dual opening detachment feature can reduce potential manufacturingchallenges to provide for reliable stretch resistant fiber positioningand therefore more reliably provide implants that can be more easilyrepositioned.

To reduce effects of push back during implantation, the detachmentfeature can be sized and affixed to the embolic coil to provide anembolic coil implant with a highly flexible proximal section. An emboliccoil implant having a highly flexible proximal section can reduce pushback force on the delivery tube and thereby mitigate the effects of thedelivery tube shifting. Additionally, or alternatively, the detachmentfeature can be sized to mate with a delivery tube having a highlyflexible distal section, and the highly flexible distal section of thedelivery tube can mitigate the effects of the delivery tube shifting.When an embolic coil implant having a highly flexible proximal sectionis mated to a delivery tube having a highly flexible distal portion, thecombination of the flexible distal section of the delivery tube and theflexible proximal section of the implant can further mitigate theeffects of delivery tube shifting.

To reduce instances of premature deployment, the detachment feature caninclude a bridge to support a pull wire. The detachment feature can bedetachably attached to a mechanical engagement/deployment system on adelivery tube. The detachment feature can include an opening throughwhich a loop wire of a mechanical engagement system can pass. In someexamples, the detachment feature can further include a bridge positioneddistally from the opening on which a distal portion of the pull wire canrest. The bridge can inhibit the pull wire from deforming due to theengagement with the loop wire and can therefore reduce the likelihoodthat the implant is prematurely released due to bending of the pullwire.

FIG. 1A is an illustration of an implant 10 a including an embolic coil12 with a lumen 13 therethrough, a detachment feature 18 a, and astretch resistant fiber 16. Portions of the coil 12 and welds 42 asillustrated in a cut-away view for the purposes of illustration. Thedetachment feature 18 a can partially be positioned within the lumen 13of the coil 12 and can extend out of the coil 12. The detachment feature18 a can include a distal opening 24 a through which the stretchresistant wire 16 is looped, and a proximal opening 22 a sized toreceive a loop wire or other engagement mechanism of a mechanicalimplant engagement system. The detachment feature 18 a can include abridge 28 a positioned between the distal opening 24 a and the proximalopening 22 a. The detachment feature 18 a can include a proximal tab 38sized to fit within a lumen of a delivery tube. The stretch resistantfiber 16 can be secured at an end of the embolic coil 12 opposite theend to which the detachment feature 18 a is attached with a weld 44 orother appropriate attachment.

The detachment feature 18 a can be tapered as it extends further withinthe lumen 13 of the embolic coil 12 to allow the embolic coil 12 to haveadditional flexibility where the embolic coil 12 surrounds the taperedregion. The detachment feature 18 a can also have a substantially flatprofile, providing even greater flexibility in directions into and outof the plane of the image.

The detachment feature 18 a can be sufficiently secured with attachments42 to the coil 12 without fusing any windings of the coil 12 (asillustrated) or by fusing a small number of windings (e.g. 5 or fewerwindings). Compared to known solutions wherein typically ten or morewindings are soldered together (with limited control over the number offused windings), the attachments 42 to the coil 12 can be realized withsignificantly fewer fused coil windings. By reducing the number ofwindings that are fused, the proximal section of the implant 10 a canhave increased flexibility compared to known designs which rely onfusing windings from the proximal end of the embolic coil.

FIG. 1B is an illustration of an alternatively constructed implant 10 bhaving elements as described in relation to FIG. 1A with like referencenumbers indicating like elements. Portions of the coil 12 and welds 42as illustrated in a cut-away view for the purposes of illustration.Compared to the implant 10 a illustrated in FIG. 1A, the implant 10 bcan have an alternative detachment feature 18 b having a single opening26 b that provides an opening to which a mechanical engagement systemcan engage and through which the stretch resistant fiber 16 can belooped. The detachment feature 18 b illustrated in FIG. 1B also lacksthe extended tapered region of the detachment feature 18 a illustratedin FIG. 1A. Although the tapered region of the detachment feature 18 aillustrated in FIG. 1A can provide for a more flexible proximal sectionof the implant 10 a compared to the implant 10 b in FIG. 1B, thedetachment feature 18 b illustrated in FIG. 1B can nevertheless providegreater flexibility over known embolic coil implants by providingflexibility in directions into and out of the plane of the image byvirtue of being flat and provide increased flexibility over designswhich rely on fusing windings from the proximal end of the embolic coilby virtue of the low profile attachments 42.

FIGS. 2A and 2B through FIG. 7 illustrate a sequence of steps forconstructing the implants 10 a and 10 b illustrated in FIGS. 1A and 1B.FIGS. 2A and 2B illustrate the stretch resistant fiber 16 being passedthrough the detachment features 18 a, 18 b. The detachment features 18a, 18 b can be laser cut from a flat sheet material. The flat sheetmaterial is preferably a radiopaque material that can be welded orotherwise affixed to the embolic coil 12.

FIG. 2A illustrates the dual opening detachment feature 18 a having aproximal portion 32 that is sized to engage a mechanical engagementsystem and/or delivery tube. The proximal portion 32 is illustrated ashaving a width W1. The dual opening detachment feature 18 a can have adistal portion 34 that is sized to fit within the lumen 13 of theembolic coil. The distal portion 34 can have a wider section having awidth W2 that is about as wide as the inner diameter of the embolic coil12 and a tapered section having a width W3 that is significantlynarrower than the inner diameter of the embolic coil 12. The detachmentfeature 18 a can have a proximal tab 38 that is narrower than theproximal portion 32 and is sized to fit within a lumen of a deliverytube.

FIG. 2B illustrates a single opening detachment feature 18 b having aproximal portion 32 that is sized to engage a mechanical engagementsystem and/or delivery tube. The proximal portion 32 is illustratedhaving a width W1. The single opening detachment feature 18 b can have adistal portion 34 b narrower than the proximal portion 32 and sized tofit within the lumen 13 of the coil 12. The single opening detachmentfeature 18 b can have a proximal tab 38 that is narrower than theproximal portion 32 and sized to fit within a lumen of a delivery tube.

After the detachment feature 18 a, 18 b is formed, the stretch resistantfiber 16 can be threaded through the distal opening 24 a of the dualopening detachment feature 18 a or the single opening 26 b of the singleopening detachment feature 18 b.

FIG. 3 is an illustration of the free ends of the stretch resistantfiber 16 being inserted into the proximal end 15 of the embolic coil 12.At the step illustrated in FIG. 3 , the stretch resistant fiber 16 canbe looped through a detachment feature 10 a, 10 b such as illustrated inFIGS. 2A and 2B.

FIG. 4 is an illustration of the free ends of the stretch resistantfiber 16 exiting the lumen 13 of an embolic coil 12 at the distal end 14of the embolic coil 12.

FIGS. 5A and 5B are illustrations of detachment features 18 a, 18 bbeing inserted into the lumen 13 of an embolic coil 12. After exitingthe distal end 14 of the embolic coil 12, the free ends of the stretchresistant fiber 16 can be further pulled as indicated by the arrow inFIG. 4 to move the detachment feature 18 a, 18 b into the lumen 13 ofthe embolic coil 12 at the proximal end 15 of the embolic coil 12 asillustrated in FIGS. 5A and 5B and as indicated by the arrows. Beforeentry of the detachment feature 18 a, 18 b into the lumen 13 of theembolic coil 12, the embolic coil can have an inner diameter D asindicated in FIG. 5A. The proximal portion 34 of the detachment feature18 a, 18 b can be sized to have a width over at least a portion of thedistal portion 34 that is about equal to the inner diameter D for a snugfit. Alternatively, or additionally, at least a portion of the distalportion 34 can have a width that is larger than the diameter D to createan interference fit. Alternatively, or additionally, at least a portionof the distal portion 34 can have a width that is smaller than thediameter D to allow for greater flexibility of the coil 12 near theproximal end 15 of the coil 12.

FIGS. 6A and 6B are illustrations of the detachment features 10 a, 10 bwith the distal portion 34 fully inserted into the lumen 13 of theembolic coil 12 and the detachment feature 18 a, 18 b affixed to theembolic coil 12 with welds 42 or other attachment. In both FIGS. 6A and6B, the detachment feature 18 a, 18 b is illustrated having a distalportion 34 that has a width over at least a portion of the length of thedistal portion 34 that is about equal to the inner diameter D of thelumen 13 of the embolic coil 12.

FIG. 7 is an illustration of the stretch resistant fiber 16 affixed tothe distal end of the embolic coil 12. After affixing the detachmentfeature 18 a, 18 b, or at least positioning the detachment feature 18 ato 18 b as illustrated in FIGS. 6A and 6B, the stretch resistant fiber16 can be pulled tight to reduce slack in the fiber 16 and/or createtension in the fiber 16, and the fiber 16 can be affixed with a weld 44or other attachment. After the fiber 16 is attached, the fiber can besubstantially stretch resistant as to resist significant elongation dueto forces applied to the embolic coil 12 during preparation fortreatment, during delivery of the implant 10 a, 10 b, during positioningof the implant in a treatment site, during retraction of the implant,and during deployment of the implant. In other words, the stretchresistant fiber 16 can be effective to limit lengthening of the emboliccoil 12 when the embolic coil 12 is retracted from an aneurysm, and thestretch resistant fiber 16 can be effective to limit separation of thewindings within the embolic coil 12 when the embolic coil 12 is bent.

FIGS. 8A through 8C illustrate a time sequence wherein the embolic coil12 is allowed to stretch as a result of a non-optimal stretch resistantfiber 16 placement. FIG. 8A illustrates a non-optimal fiber 16 placementwithin the single opening detachment feature 18 b. The fiber 16 canbecome looped over a section of the detachment feature 18 b that is notoptimal such that movement of the fiber 16 as illustrated in FIG. 8B cancause the fiber 16 to disengage from the non-optimal position, and asillustrated in FIG. 8C, can allow the embolic coil 12 to stretch atleast until the fiber 16 again becomes engaged to the detachment feature18 a. A manufacturing challenge is therefore to prevent the fiber 16from being positioned at a non-optimal location such as illustrated inFIG. 8A when the attachment step illustrated in FIG. 7 is performed. If,after manufacturing is complete, the fiber 16 becomes dislodged from thenon-optimal location as illustrated in FIG. 8B, when the implant 10 b ismanipulated, such as while being repositioned during a treatment, theembolic coil 12 can elongate as illustrated in FIG. 8C or otherwisedeform.

An advantage of the dual opening detachment feature 18 a is that thestretch resistant fiber 16 is less likely to become looped over anon-optimal section of the detachment feature 18 a during manufacturingof the implant 10 a illustrated in FIG. 1A.

FIG. 9 is an illustration of embolic implant(s) 10 being deliveredthrough a delivery catheter 200 and positioned within an aneurysm A on ablood vessel BV. The implant(s) can loop and bend within the aneurysmsac to form a thrombotic mass. The implant(s) can loop back onthemselves and/or loop next to other implants. As the aneurysm A becomesincreasingly packed, overlapping portions of the implant 10 can pressinto each other.

FIG. 10A is an illustration of embolic coils 12 that lack a stretchresistant fiber 16 becoming tangled as overlapping portions of the coilspress into each other. This entanglement can make it difficult orimpossible for either of the coils 12 to be repositioned, which is aknown problem with some current embolic coil implants. FIG. 10Billustrates a portion of the embolic coil 12 becoming elongated to alength L2 that is longer than the length L1 of that section illustratedin FIG. 10A due to a force F. FIG. 10B illustrates a scenario wherein aphysician may try to attempt to retract a tangled partially implantedembolic coil and may be not only unable to retract the coil but alsoexacerbate the already challenging treatment by now having to positionthe deformed elongated coil. Entanglement can become more likely whenthe windings of the embolic coil are separated, for example due tobending, or when the coils are more tightly pressed together due todense packing.

FIG. 11 is an illustration of example embolic coils 12 each having astretch resistant fiber 16 being prevented from tangling and fromelongating according to an aspect of the present invention. Each coil 12is illustrated as having a bent portion 20. The stretch resistant fiber16 can shift within the lumen 13 of each coil to allow the coil 12 toflex and bend as needed when implanted. The fiber 16 can have sufficienttension to limit the amount of separation between windings in the bentportions 20. The separation of the winds can be so limited as to inhibitthe windings of two adjacent coils 12 from becoming entangled asillustrated in FIG. 10A. FIG. 11 also illustrates the force F applied toa portion 40 of the coil 12 and the portion 40 being inhibited fromelongating due to tension in the stretch resistant fiber 16. FIG. 11illustrates a scenario wherein a physician may successfully retract apartially implanted embolic coil 12 having a stretch resistant fiber 16therethrough.

FIG. 12 is a flow diagram illustrating a method 500 including steps thatcan be conducted as part of an aneurysm treatment using an exampleimplant 10, 10 a, 10 b such as described herein. In step 510, an implanthaving an embolic coil and stretch resistant fiber can be positioned atleast partially within an aneurysm sac. In step 520, a portion of theembolic coil can be bent. In step 530, as the coil is bent, the stretchresistant fiber can inhibit separation of windings within the bentportion of the embolic coil. In step 540, some or all of the implantedportion of the implant can be retracted from the aneurysm. In step 550,as the implant is retracted, the stretch resistant fiber can inhibitlengthening of the embolic coil.

FIG. 13 is an illustration of an example embolic implant 10 such aseither implant 10 a, 10 b illustrated in FIGS. 1A and 1B or otherwisedescribed herein secured to a delivery tube 300. Example delivery tubesand engagement/deployment systems are described in U.S. PatentPublication Number 2019/0192162 and U.S. patent application Ser. No.15/964,857, now U.S. Publication No. 2019/0328398 A1 each incorporatedherein by reference. The delivery tube 300 can include a notch 310 sizedto receive the proximal portion 32 of the detachment feature 18 of theimplant 10, and likewise the proximal portion 32 of the detachmentfeature 18 can be sized to fit within the notch 310 of the delivery tube300. FIG. 13 illustrates a side view of the implant 10 highlighting theflat profile of the detachment feature 18. As described in relation toFIGS. 1A and 1B, the implant 10 can have a highly flexible proximalsection by virtue of the detachment feature 18 being flat and/or byvirtue of the detachment feature 18 being secured to the coil 12 withoutfusing several coil windings. The detachment feature 18 can also betapered for increased flexibility in directions into and out of theplane of the image. The detachment feature 18 can further include aproximal tab 38 positioned within the lumen of the delivery tube 300.

During an aneurysm occlusion treatment, lack of flexibility of theproximal section of known embolic implants and/or lack of flexibility ofa distal portion of a delivery tube can cause the delivery tube to pullback from the treatment site or otherwise move out of position while theimplant is being placed in the aneurysm. A delivery tube having a moreflexible distal portion and an implant having a more flexible proximalsection, alone or in combination, can therefore provide a more stablesystem for delivering the implant. Flexible structures, however can tenddeform or expand when manipulated. The stretch resistant fiber 16 and/ordetachment feature 18 alone or in combination can support the coil 12and inhibit deformation and expansion of the coil 12 according to theprinciples described herein. An object of the present invention is toprovide an implant 10 having a highly flexible proximal section and/orconfigured to mate with a delivery tube 300 having a highly flexibledistal portion.

FIG. 14A is an illustration of the implant 10 and delivery tube 300configured for delivery and positioning of the implant 10. FIGS. 14Bthrough 14D are illustrations of a sequence of steps for releasing theexample embolic implant 10 from the delivery tube 300. A portion of thedelivery tube 300 is cut away for illustration purposes.

FIG. 14A illustrates the engagement system including a pull wire 140 anda loop wire 400 locked into the detachment feature 18 of the implant 12.The delivery tube 300 can include a compressible portion 306 that can becompressed. The loop wire 400 can have an opening 405 at a distal end404 of the loop wire 400, and the opening 405 can be placed through anopening 22 a in the detachment feature 18. When the pull wire 140 is putthrough the opening 405 the implant 12 is now secure.

The detachment feature 18 can include a bridge 28 positioned distallyfrom the loop wire opening 405 and positioned to support a distalportion of the pull wire 140 that is distal of where the loop wireopening 405 is supported by the pull wire 140. Configured thusly, thebridge 28 can support the distal portion of the pull wire 140 such thatwhen the loop wire 400 tugs on the pull wire 140 at the loop opening405, the bridge 28 can inhibit the distal portion of the pull wire 140from deforming. The proximal tab 38 can positioned to support a portionof the pull wire 140 that is proximal of where the loop wire opening 405is supported by the pull wire 140. The combination of the bridge 28 andthe proximal tab 38 can inhibit the pull wire 140 from deforming due toforces applied by the loop wire 400. The delivery tube 300 can bedetachably attached to the implant 10 as illustrated in FIG. 14A duringdelivery of the implant 10 through the vasculature and while the implant10 is being positioned at a treatment site. The bridge 28 can reduce thelikelihood that the implant 10 is prematurely released due to bending ofthe pull wire 140 due to forces from the loop wire 400.

The bridge 28 can separate a proximal opening 22 a and a distal opening24 a in a dual opening implant as illustrated. It is also contemplatedthat a single opening implant can be adapted to include a structure thatcan function to support the distal portion of the pull wire 140 similarto as described in relation to the illustrated bridge 28. Alternativebridge structures are therefore intended to be within the scope of thepresent invention.

FIG. 14B illustrates the pull wire 140 being drawn proximally to beginthe release sequence for the implant 10. FIG. 14C illustrates theinstant the pull wire 140 exits the opening 405 and is pulled free ofthe loop wire 400. The distal end 404 of the loop wire 400 falls awayand exits the locking portion 18. As can be seen, there is now nothingholding the implant 10 to the delivery tube 300. FIG. 14D illustratesthe end of the release sequence. Here, the compressible portion 306 hasexpanded/returned to its original shape and “sprung” forward. An elasticforce E is imparted by the distal end 304 of the delivery tube 300 tothe medical device 10 to “push” it away to ensure a clean separation anddelivery of the medical device 10.

FIG. 15 is a cross sectional illustration of a proximal section of analternatively constructed implant 10 c having elements as described inrelation to FIG. 1A with like reference numbers indicating likeelements. Compared to the implant 10 a illustrated in FIG. 1A, theimplant 10 c illustrated in FIG. 15 can have an alternative detachmentfeature 18 c. The detachment feature 18 c illustrated in FIG. 18 c canhave a portion with a width D2 sized to fit within a lumen 13 of anembolic coil 12 having an inner diameter D1. The width D2 of thedetachment feature 18 c can be larger than the inner diameter D1 of thecoil lumen 13 so that when the detachment feature 18 c is positionedwithin the lumen 13, a proximal portion of the lumen 13 expands to adiameter D2 to accommodate the width D2 of the detachment feature 18 c.Configured thusly, the expanded portion of the coil 12 can provide acompressive force against the section of the detachment feature havingwidth D2 to help secure the detachment feature 18 c to the coil 12.

Compared to the implant 10 a illustrated in FIG. 1A, the bridge 28 c canextend proximally from a proximal end of the embolic coil 12. Configuredthusly, in some configurations, the pull wire 140 need not be insertedinto the lumen 13 of the embolic coil 12 to be supported by the bridge28 c. Limiting the length of pull wire 140 that is inserted into theembolic coil 12 can increase the flexibility of the proximal section ofthe embolic coil.

The implant 10 c illustrated in FIG. 15 can be constructed according tothe principles illustrated in FIGS. 2A and 2B through FIG. 7 . Theimplant 10 c illustrated in FIG. 15 can be used according to theprinciples illustrated in FIGS. 9 and 11 through 14D.

As used herein, the terms “about” or “approximately” for any numericalvalues or ranges indicate a suitable dimensional tolerance that allowsthe part or collection of components to function for its intendedpurpose as described herein. More specifically, “about” or“approximately” may refer to the range of values±20% of the recitedvalue, e.g. “about 90%” may refer to the range of values from 71% to99%.

The descriptions contained herein are examples of embodiments of theinvention and are not intended in any way to limit the scope of theinvention. As described herein, the invention contemplates manyvariations and modifications of the implant and methods for making andusing the same, including alternative materials, alternative geometriesof component parts, alternative positioning of component parts inrelation to each other, etc. These modifications would be apparent tothose having ordinary skill in the art to which this invention relatesand are intended to be within the scope of the claims which follow.

What is claimed is:
 1. A method comprising: positioning some or all ofan implant comprising an embolic coil and a stretch resistant fiberwithin an aneurysm; retracting a first portion of the embolic coil fromthe aneurysm; and limiting lengthening of the first portion of theembolic coil with the stretch resistant fiber as the first portion isretracted from the aneurysm.
 2. The method of claim 1, furthercomprising: positioning the stretch resistant fiber to extend within alumen of the embolic coil.
 3. The method of claim 1, further comprising:bending a second portion of the embolic coil; and limiting, with thestretch resistant fiber, separation of windings within the secondportion of the embolic coil while bending the second portion of theembolic coil.
 4. The method of claim 1, further comprising: securing theimplant to a delivery system by a key engaged to the stretch resistantfiber; and releasing the key from the delivery system, thereby releasingthe implant from the delivery system.
 5. The method of claim 4, whereinthe step of securing the implant to the delivery system furthercomprises: positioning a loop wire of the delivery system through thekey, and positioning a pull wire of the delivery system through anopening in the loop wire; and wherein the method further comprises:supporting, by the key, a first portion of the pull wire positioned inthe distal direction in relation to the opening in the loop wire, andsupporting, by the key, a second portion of the pull wire positioned inthe proximal direction in relation to the opening in the loop wire. 6.The method of claim 4, wherein: the embolic coil comprises a lumentherethrough, the lumen comprising an inner diameter; the key comprisesa proximal portion disposed proximally from the lumen and a distalportion disposed within the lumen; the proximal portion comprises afirst width measuring greater than the inner diameter of the lumen; andthe distal portion comprises a second width measuring about equal to theinner diameter of the lumen.
 7. The method of claim 6, wherein: thelumen of the embolic coil comprises a first inner diameter in anon-expanded portion of the lumen and a second inner diameter in anexpanded portion of the lumen; the first width of the proximal portionof the key measures greater than the first inner diameter of the lumen;and the second width of the distal portion of the key measures greaterthan the first inner diameter and about equal to the second innerdiameter of the lumen.
 8. A method comprising: threading a stretchresistant fiber through a first opening in a detachment feature;extending the stretch resistant fiber through a lumen of an emboliccoil; affixing the detachment feature to a first end of the emboliccoil; affixing the stretch resistant fiber to a second end of theembolic coil opposite the first end; and providing tension along thestretch resistant fiber between the detachment feature and the secondend of the embolic coil.
 9. The method of claim 8, further comprising:cutting the detachment feature from a flat sheet material; cutting thefirst opening in the detachment feature; and extending a portion of amechanical deployment system through the first opening to engage thedetachment feature to a delivery tube.
 10. The method of claim 8,further comprising: cutting the detachment feature from a flat sheetmaterial; cutting the first opening in the detachment feature; cutting asecond opening in the detachment feature separate from the firstopening; and extending a portion of a mechanical deployment systemthrough the second opening to engage the detachment feature to adelivery tube.
 11. The method of claim 8, further comprising: cuttingthe detachment feature from a radiopaque flat sheet material.
 12. Themethod of claim 8, further comprising: inserting a distal portion of thedetachment feature within the lumen of the embolic coil; and extending aproximal portion of the detachment feature proximally from a proximalend of the embolic coil.
 13. The method of claim 12, further comprising:selecting the embolic coil such that the lumen comprises an innerdiameter; and selecting the detachment feature such that the proximalportion of the detachment feature comprises a first width measuringgreater than the inner diameter of the lumen and such that the distalportion of the detachment feature comprises a second width measuringabout equal to the inner diameter of the lumen.
 14. The method of claim13, further comprising: selecting the embolic coil such that the lumencomprises a first inner diameter in a non-expanded portion of the lumenand a second inner diameter in an expanded portion of the lumen; andselecting the detachment feature such that the proximal portion of thedetachment feature comprises the first width measuring greater than thefirst inner diameter of the lumen and the second width measuring greaterthan the first inner diameter and about equal to the second innerdiameter of the lumen.
 15. The method of claim 8, wherein affixing thedetachment feature to a first end of the embolic coil comprises weldingthe detachment feature to the first end of the embolic coil.